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Jan 21, 2011

NICE moves toward approval of Avastin for AMD in BritainThe NHS in the United Kingdom has moved a step closer to approving Avastin to for the treatment of age-related macular degeneration (AMD), in spite of attempts by drug companies to block it.

The National Institute for Health and Clinical Excellence (Nice), which decides which drugs may be prescribed on the NHS, has decided to move towards an official appraisal of a drug, Avastin, that has been widely and cheaply used in the treatment of wet AMD – even though the drug companies that make and market it refuse to seek a licence. They have a licensed version which is many times more expensive.

Avastin is licensed for bowel cancer, but ophthalmologists in the US discovered that – split into tiny doses suitable for injection into the eye – it could halt and even reverse the progress of wet AMD, which is the commonest cause of blindness. Eye specialists around the world have been using Avastin in this way, because splitting a vial into many tiny doses makes it relatively cheap.

But the manufacturer, Genentech, and the Swiss drugs company Roche, which markets Avastin in Britain, have fought this use. Genentech has produced and licensed a very similar but far more costly version, which it calls Lucentis, and which has been approved by Nice for the NHS.

The Royal Liverpool and Broadgreen University Hospitals pharmacy, which has been producing Avastin for eyes, charges £50 a dose. Mass production could bring the cost still lower. Lucentis costs around £750 a dose.

The treatment involves one injection a month for three months, and more if the patient's sight continues to deteriorate. Because of Nice's concerns over the cost, Novartis, which markets Lucentis here, agreed to pay for any patient who needed more than 14 injections of that drug. But with 20,000 people diagnosed with wet AMD every year in Britain, the bill is high.

Nice rarely appraises unlicensed drugs, but has decided that it will do so with Avastin for eyes, subject to help from the licensing authority with assessing safety and quality. It now needs the go-ahead from the Department of Health.

The decision will not be welcomed by the drug companies. Roche, which has bought Genentech, said it had decided not to apply for a licence for eyes "due to corporate considerations" and had no plans to reconsider that decision. The drug companies warned Nice that the safety of Avastin in eyes could not be properly monitored without their involvement – and they were not willing to help. "As a consequence, these stakeholders suggested that an appraisal would not be appropriate."

The Royal National Institute of Blind People, which receives funding from the companies, also opposed the appraisal, arguing – as the companies did – that there was not enough evidence of Avastin's safety and there will not be unless the licence-granting bodies look at it. Nice's role, it said in its submission, "is to assess the efficacy and cost-effectiveness of new drugs in relation to existing treatments or best supportive care. Any attempt to change this 'division of labour' requires changes to the regulatory system and therefore political decisions that go far beyond this exploratory work."

But in a cash-strapped NHS, there are already primary care trusts that have voted with their feet. Stockport PCT offers Avastin to patients at a private hospital, or Lucentis at an NHS hospital which has a waiting list of four to five weeks. Patients are given very detailed information about both drugs, but usually opt for Avastin. Stockport PCT estimates it will have 200 new patients every year who could benefit from the drugs. It would cost £1m more a year to treat them with Lucentis rather than Avastin, it says.

Bury PCT was using Avastin before Lucentis got Nice approval but is going back to Avastin, adopting the Stockport model. Peter Elton, public health director at Bury, says there is potentially an even bigger issue at stake. The licensing laws at the moment favour the drug companies. But approval for an unlicensed use of Avastin could open the door for other drugs to be appraised and used in the NHS, especially for "orphan" conditions – where the small number of sufferers does not make it commercially worthwhile for a drug company to conduct the trials necessary to get a licence.